Lead Environmental Monitoring Specialist

2 weeks ago

Concord, New Hampshire, United States BioSpace, Inc. Full time
Job Title: Lead Environmental Monitoring Technician

At BioSpace, Inc., we are dedicated to providing innovative solutions for the pharmaceutical industry. We are seeking a highly skilled Lead Environmental Monitoring Technician to join our team.

Job Summary:

The Lead Environmental Monitoring Technician will be responsible for providing oversight and guidance for the Environmental Monitoring Technicians. This role will assist in the coordination of environmental monitoring activities, training, and routine environmental monitoring and utility sampling in the manufacturing areas.

Key Responsibilities:
  • Ensure and enforce compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices.
  • Provide support for Parenteral Operations activities by performing environmental monitoring of classified manufacturing areas.
  • Provide support for manufacturing and laboratory activities by performing utility sampling and analysis within the Parenteral Operations and QC Laboratory buildings.
  • Assist management in providing oversight of the Environmental Monitoring Technicians during the day-to-day activities, including any non-routine day-to-day activities that may arise based on production needs.
  • Assist management in coordinating environmental monitoring activities for the Environmental Monitoring Technician(s).
  • Perform technical training and mentor Environmental Monitoring Technicians through formal process/program.
  • Provide shift support for Environmental Monitoring Technicians when non-routine events occur and escalate to management as required.
  • Assist with authoring Standard Operating Procedures and Work Instruction documentation.
  • Adhere to and promote compliance of all safety standards.
  • Perform environmental monitoring of classified manufacturing areas for Parenteral Operations activities.
  • Perform utility sampling and analysis for manufacturing and QC laboratory.
Requirements:
  • High School Diploma or equivalent, Associate's degree or equivalent, Bachelor's (4-year) degree in a science related field is preferred.
  • 2 - 3+ years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production.
  • Demonstrated ability in performing environmental monitoring techniques including, but not limited to viable surface monitoring, viable and non-viable air monitoring, compressed air monitoring, and water (potable, purified water, water for injection, clean steam) collection and analysis.
  • Previous experience with Laboratory IT systems such as LIMs, LES, and MODA.
Preferred Qualifications:
  • High level of experience with cGMP requirements, compliance, and regulatory guidance associated with a cGMP Pharmaceutical Manufacturing facility.
  • Possess interpersonal skills and teaching/coaching experience.
  • Possess oral and written communication skills for communicating to employees, management, and other departments.
  • Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
  • Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.
Work Environment:

The role will be phased from a project support role to a routine support role as the development facility and processes progress. Tasks may require repetitive motion and standing or walking for long periods of time. Tasks may require lifting of up to 30 pounds and may require the ability to pass, push, and pull to execute specific aspects of the job role. During the project phase the working schedule will vary (typically M-F 8 hours). In operation, must have ability to work 12-hour night shift (2-2-3 structure). Travel will be required during the project phase for training and implementation of the Environmental Monitoring Program for the Concord site.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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